Prescribing Information

Aveed (testosterone undecanoate) Injection is a form of the male hormone, testosterone, used for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Common side effects include acne, injection site pain, PSA increase, fatigue, irritability, insomnia, mood swings, aggression, difficulty ejaculating, and weight gain.

The recommended dose of Aveed is 3 mL (750 mg) injected intramuscularly, followed by 3 mL (750 mg) injected after 4 weeks, then 3 mL (750 mg) injected every 10 weeks thereafter. Aveed may interact with insulin, anticoagulants, and corticosteroids. Tell your doctor all medications and supplements you use. Aveed is not recommended for use in women, therefore it is unlikely to be used during pregnancy or while breastfeeding. Withdrawal symptoms may occur if you stop taking this medication.

Our Aveed (testosterone undecanoate) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in clinical practice.

During the 84-week clinical
trial, the average serum PSA increased from 1.0 ± 0.8 ng/mL at baseline to 1.5
±1.3 ng/mL at the end of study. Fourteen patients (10.9%) in whom the baseline
PSA was < 4 ng/mL had a post-baseline serum PSA of > 4 ng/mL during the
84-week treatment period.

A total of 725 hypogonadal men
received intramuscular testosterone undecanoate in a total of 7 controlled
clinical trials. In these clinical trials, the dose and dose frequency of
intramuscular testosterone undecanoate varied from 750 mg to 1000 mg, and from
every 9 weeks to every 14 weeks. Several of these clinical trials incorporated
additional doses upon initiation of therapy (e.g., loading doses). In addition
to those adverse reactions noted in Table 1, the following adverse events were
reported by at least 3% of patients in these trials, irrespective of the
investigator's assessment of relationship to study medication: sinusitis,
prostatitis, arthralgia, nasopharyngitis, upper respiratory tract infection,
bronchitis, back pain, hypertension, diarrhea and headache.

Adverse events attributable to
pulmonary oil microembolism and anaphylaxis were reported in a small number of
patients in controlled clinical trials. In the 84-week clinical trial of Aveed,
1 patient experienced a mild coughing fit lasting 10 minutes after his third
injection, which was retrospectively attributed to POME. In another clinical
trial of intramuscular testosterone undecanoate (1000 mg), a hypogonadal male
patient experienced the urge to cough and respiratory distress at 1 minute
after his tenth injection, which was also retrospectively attributed to POME.

During a review that involved
adjudication of all cases meeting specific criteria, 9 POME events in 8
patients and 2 events of anaphylaxis among 3,556 patients treated with
intramuscular testosterone undecanoate in 18 clinical trials were judged to
have occurred.

Postmarketing Experience

The following adverse reactions
have been identified during post-approval use of Aveed. Because the reactions
are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.

Pulmonary Oil Microembolism
(POME) and Anaphylaxis

Serious pulmonary oil
microembolism (POME) reactions, involving cough, urge to cough, dyspnea,
hyperhidrosis, throat tightening, chest pain, dizziness, and syncope, have been
reported to occur during or immediately after the injection of intramuscular
testosterone undecanoate 1000 mg (4 mL) in post-approval use outside the United
States. The majority of these events lasted a few minutes and resolved with
supportive measures; however, some lasted up to several hours and some required
emergency care and/or hospitalization.

In addition to serious POME reactions, episodes of
anaphylaxis, including life-threatening reactions, have also been reported to
occur following the injection of intramuscular testosterone undecanoate in
post-approval use outside of the United States.

Both serious POME reactions and anaphylaxis have been
reported to occur after any injection of testosterone undecanoate during the
course of therapy, including after the first dose.

Other Events

The following treatment emergent adverse events or
adverse reactions have been identified during post-marketing clinical trials
and during post-approval use outside the United States of intramuscular
testosterone undecanoate. In most cases, the dose being used was 1000 mg.